gentle

gentle
SPL v1
SPL
SPL Set ID 95d86f89-f57e-4614-8dca-2460b617fe97
Route
topical
Published
Effective Date 2020-08-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (70 mL)
Inactive Ingredients
carbomer homopolymer, unspecified type edetic acid glycerin polysorbate 20 trolamine water

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-08-01

Purpose

Antiseptic

Description

Ethyl alcohol 70%


Medication Information

Warnings

Flammable, keep away from fire/flame

For external us e only

Do not use

• in children less than 2 months of age

• open skin wounds

When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water 

Stop use and ask a doctor if

• irritation and redness develop

• condition persists for more than 72 hours.

Purpose

Antiseptic

Directions

• wet hands thoroughly with product and allow to dry without wiping

• supervise children under 6 years of age when using this product to avoid swallowing

Other Information

• store between 15-30˚C (59-86˚F)

• avoid freezing and excessive heat above 40˚C (104˚F)

Inactive Ingredients



carbomer, EDTA, glycerol, polysorbate, triethanolamine, water

Description

Ethyl alcohol 70%

Use

• hand sanitizer to decrease bacteria on the skin

• recommended for repeated use

• for use when soap and water are not available

Section 42229-5

LOT NO. AND EXPIRY

PRINTED ON BOTTLE

Distributed by: Roldan Industries

1500 E Tropicana Ave. Ste 154 Las Vegas NV 89119

COUNTRY OF ORIGIN: MEXICO

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Packaging

Questions? +

You may also report serious side effects to this phone number. Mon - Fri 9:00 AM - 5:00 PM

drug Facts

Active Ingredient

Ethyl alcohol 70%


Structured Label Content

Warnings

Flammable, keep away from fire/flame

For external us e only

Do not use

• in children less than 2 months of age

• open skin wounds

When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water 

Stop use and ask a doctor if

• irritation and redness develop

• condition persists for more than 72 hours.

Purpose

Antiseptic

Directions

• wet hands thoroughly with product and allow to dry without wiping

• supervise children under 6 years of age when using this product to avoid swallowing

Other Information (Other information)

• store between 15-30˚C (59-86˚F)

• avoid freezing and excessive heat above 40˚C (104˚F)

Inactive Ingredients (Inactive ingredients)



carbomer, EDTA, glycerol, polysorbate, triethanolamine, water

Use

• hand sanitizer to decrease bacteria on the skin

• recommended for repeated use

• for use when soap and water are not available

Section 42229-5 (42229-5)

LOT NO. AND EXPIRY

PRINTED ON BOTTLE

Distributed by: Roldan Industries

1500 E Tropicana Ave. Ste 154 Las Vegas NV 89119

COUNTRY OF ORIGIN: MEXICO

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Packaging

Questions? +

You may also report serious side effects to this phone number. Mon - Fri 9:00 AM - 5:00 PM

drug Facts (Drug Facts)

Active Ingredient (Active ingredient)

Ethyl alcohol 70%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)